Safety and Effectiveness of BOTOX® for Lateral Canthal Lines With or Without Simultaneous Glabellar Lines in Korea

Completed

• Conditions: Crow's Feet Lines; Lateral Canthal Lines
• Interventions: Biological: Botulinum Toxin Type A

• Registration Number: NCT02248844
• Lead Sponsor: Allergan

Brief Summary

This is a postmarketing surveillance study in Korea to evaluate the safety and effectiveness of BOTOX® for lateral canthal lines (crow's feet lines) with or without simultaneous glabellar lines.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2014-09-23
• Study First Submitted QC: 2014-09-24
• Study First Posted: 2014-09-25
• Study Start: 2014-09-26
• Primary Completion: 2017-08-14
• Study Completion: 2017-08-14
• Status Verified: 2019-07
• Last Update Submitted: 2019-07-02
• Last Update Posted: 2019-07-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 667

Inclusion Criteria

• Subject and Investigator decision to treat crow's feet lines with Botox®

Exclusion Criteria

• None

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Botulinum Toxin Type A	Botulinum Toxin Type A	Subjects who receive botulinum toxin Type A injected into crow's feet line areas per clinical practice.

Primary Outcome Measures

Name	Time	Method
Number of Participants with Adverse Events	Up to 3 months

Secondary Outcome Measures

Name	Time	Method
Investigator's Assessment of Change in Appearance of Crow's Feet Lines on a 3-Point Scale	Baseline, Up to 3 months
Subject's Assessment of Change in Appearance of Crow's Feet Lines on a 7-Point Scale	Baseline, Up to 3 months

Trial Locations

Locations (1)

Dr. Robbin Clinic; 🇰🇷 Gangnam-gu, Seoul, Korea, Republic of